Esophageal Squamous Cell CarcinomaNCT03713749
Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial
A study testing Robot esophagectomy (RE) in people with Esophageal Squamous Cell Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Robot esophagectomy (RE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Oct 2018to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18~80
- Histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN LND.
- Patients should have a performance status 0, 1 or 2 according to the European Clinical Oncology Group.
- Surgical resectable(cT1~4a, N0~3, M0)
- Written informed consent
Who cannot join
- Previous major thoracic surgery rendering minimal invasive approach unfeasible
- prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up
- inability to provide oral or written informed consent.
- pre-existed vocal cord dysfunction will also be excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung memorial hospital-Linkou
Taoyuan, 333
Yin-Kai Chao, +886-3-3281200 ext. 3633, chaoyk@gmail.com
Yin Kai Chao, MD
About this study
Official title: Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial
The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.
Read the detailed description
Radical lymph node dissection (LND) along the recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question as to whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.
The investigators will conduct a multicenter, open-label, randomized controlled trial (termed REVATE) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as 1) failure to remove lymph nodes along the left RLN or 2) occurrence of left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Robot esophagectomy (RE)
- Keywords
- Robotic esophagectomy, Video-assisted thoracoscopic esophagectomy, Recurrent laryngeal nerve lymh node, Esophageal squamous cell carcinoma
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot esophagectomy (RE)Device
Patients in RE group will receive Robotic-assisted surgery in thoracic phase.
| Study group | Role | What they receive |
|---|---|---|
| Robot Esophagectomy (RE) | Experimental | Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy. Receives: Device: Robot esophagectomy (RE) |
| Video-assisted thoracoscopic esophagectomy (VATE) | No intervention | Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of unsuccessful LND along the left RLN
Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a nexile laryngoscope within one week of surgery. RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary [i.e., recovering within 6 months] versus permanent [i.e. not recovering within 6 months]); and type of treatment required (type I: no therapy required; type II: injury requiring an elective surgical procedure; type III: injury requiring an urgent surgical procedure)
Measured: Till 6 months postoperatively
Secondary outcomes (20)
The number of nodes removed along the right and left RLN
number of lymph node removed
Measured: The pathological analysis will be finished within 2 weeks.
Post esophagectomy pneumonia rate
Post esophagectomy pneumonia is defined according to the Revised Uniform Pneumonia Score which includes temperature[°C](Range ≥ 36.1 and ≤ 38.4 =0, ≤ 36.0 and ≥ 38.5=1); leukocyte count [×1000/uL](≥ 4.0 and ≤ 11.0=0, <4.0 or >11.0=1); and pulmonary radiography(Range No infiltrate=0, Diffused or patchy infiltrate=1, Well-circumscribed infiltrate=2). A sum score of 2 points or higher, of which at least 1 point is assigned because of infiltrative findings on pulmonary radiography, indicates the presence of pneumonia.
Measured: Duration of hospital stay, an expected average of 2~3 weeks
Rate of major postoperative complication
Complication grade: modified Clavien-Dindo classification (MCDC) grade 2-4 Major complications (MCDC grade 2-4) Including: myocardial infarction, anastomotic leakage (clinical or radiologic diagnosis), anastomotic stenosis, chylothorax (chylous leakage, presence of chylous in chest tubes or indication start medium chain triglycerides containing tube feeding, gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis.
Minor complications (MCDC grade 1) Including: wound infections, pleural effusions, delayed gastric emptying
Measured: Duration of hospital stay, an expected average of 2~3 weeks
In hospital, 30 day and 90 day mortality
Death occurred during the same hospitalization , within 30 and 90 days after surgery
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 90 days
R0 resection rate
Microscopically negative proximal/distal and circumferential margin
Measured: The pathological analysis will be finished within 2 weeks.
Operation time(thoracic phase)
thoracic phase operation time(minutes)
Measured: Day of surgery
Operation time(abdominal)
abdominal phase operation time(minutes)
Measured: Day of surgery
Total operation time
total surgical time (expressed in minutes)
Measured: Day of surgery
Unexpected events and complications occurring during surgery
massive hemorrhage, perforation of other organs
Measured: Day of surgery, up to 24 hours after surgery.
Blood loss during surgery
blood loss during surgery (expressed in mL per phase)
Measured: Day of surgery, up to 24 hours after surgery.
Rate of thoracotomy conversion
Number of patients requiring conversion to thoracotomy and related reasons
Measured: Day of surgery, up to 24 hours after surgery.
Length of mechanical ventilator use after surgery
expressed in minutes
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Length of intensive care unit stay after surgery
expressed in hours
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Length of postoperative hospital stay
expressed in days , calculated from the date of surgery to date of discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Re-intubation rate
Need for re-intubation after extubation
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Re-entry ICU rate
Need to transfer back from ward to ICU after surgery
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Overall survival rate
From date of surgery until the date of death from any cause
Measured: Assessed 24/36/60 months after surgery
Disease free survival rate
From date of surgery until the date of first documented recurrence
Measured: Assessed up to 24/36/60 months after surgery
Hospital Anxiety and Depression Scale (HADS)
The HADS aims to measure symptoms of anxiety and depression and consists of 14 items,seven items for the anxiety subscale and seven for the depression subscale. The questionnaire responses were analysed in the light of the results of this estimation of the severity of both anxiety and of depression. This enabled a reduction of the number of items in the questionnaire to just seven reflecting anxiety and seven reflecting depression.(Of the seven depression items five reflected aspects of reduction in pleasure response). Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. a score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.
Measured: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.
European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18
The EORTC QLQ-C30 incorporates a range of QOL issues in five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health/QOL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The EORTC QLQ-OES18 contains four symptom scales (dysphagia, eating disorders, reflux, and pain) and six single items (difficulty swallowing saliva, choking, dry mouth, taste disorder, cough, and speech-related issues). Each question has four response choices ranging from 1 (not at all) to 4 (very much), except for the global QOL scale, which has seven response options ranging from 1 (very poor) to 7 (excellent). All questionnaire responses are linearly transformed to scores from 0 to 100.
Measured: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start22 Oct 2018
- Primary completion22 Apr 2022 (estimated)
- Study completion22 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713749
- Sponsor's protocol ID
- 201800322A3C601
- Status last verified
- Mar 2021
- First submitted
- 11 Oct 2018
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Udagawa H, Ueno M, Shinohara H, Haruta S, Kaida S, Nakagawa M, Tsurumaru M. The importance of grouping of lymph node stations and rationale of three-field lymphoadenectomy for thoracic esophageal cancer. J Surg Oncol. 2012 Nov;106(6):742-7. doi: 10.1002/jso.23122. Epub 2012 Apr 13.
PubMed 22504922Mizutani M, Murakami G, Nawata S, Hitrai I, Kimura W. Anatomy of right recurrent nerve node: why does early metastasis of esophageal cancer occur in it? Surg Radiol Anat. 2006 Aug;28(4):333-8. doi: 10.1007/s00276-006-0115-y. Epub 2006 May 23.
PubMed 16718401Sato Y, Kosugi S, Aizawa N, Ishikawa T, Kano Y, Ichikawa H, Hanyu T, Hirashima K, Bamba T, Wakai T. Risk Factors and Clinical Outcomes of Recurrent Laryngeal Nerve Paralysis After Esophagectomy for Thoracic Esophageal Carcinoma. World J Surg. 2016 Jan;40(1):129-36. doi: 10.1007/s00268-015-3261-8.
PubMed 26464155Fujita H, Sueyoshi S, Tanaka T, Fujii T, Toh U, Mine T, Sasahara H, Sudo T, Matono S, Yamana H, Shirouzu K. Optimal lymphadenectomy for squamous cell carcinoma in the thoracic esophagus: comparing the short- and long-term outcome among the four types of lymphadenectomy. World J Surg. 2003 May;27(5):571-9. doi: 10.1007/s00268-003-6913-z. Epub 2003 Apr 28.
PubMed 12715226Gockel I, Kneist W, Keilmann A, Junginger T. Recurrent laryngeal nerve paralysis (RLNP) following esophagectomy for carcinoma. Eur J Surg Oncol. 2005 Apr;31(3):277-81. doi: 10.1016/j.ejso.2004.10.007.
PubMed 15780563Berry MF, Atkins BZ, Tong BC, Harpole DH, D'Amico TA, Onaitis MW. A comprehensive evaluation for aspiration after esophagectomy reduces the incidence of postoperative pneumonia. J Thorac Cardiovasc Surg. 2010 Dec;140(6):1266-71. doi: 10.1016/j.jtcvs.2010.08.038. Epub 2010 Sep 29.
PubMed 20884018Hulscher JB, van Sandick JW, Devriese PP, van Lanschot JJ, Obertop H. Vocal cord paralysis after subtotal oesophagectomy. Br J Surg. 1999 Dec;86(12):1583-7. doi: 10.1046/j.1365-2168.1999.01333.x.
PubMed 10594510Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603.
PubMed 22668811Zhou C, Zhang L, Wang H, Ma X, Shi B, Chen W, He J, Wang K, Liu P, Ren Y. Superiority of Minimally Invasive Oesophagectomy in Reducing In-Hospital Mortality of Patients with Resectable Oesophageal Cancer: A Meta-Analysis. PLoS One. 2015 Jul 21;10(7):e0132889. doi: 10.1371/journal.pone.0132889. eCollection 2015.
PubMed 26196135Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
PubMed 22552194Noshiro H, Iwasaki H, Kobayashi K, Uchiyama A, Miyasaka Y, Masatsugu T, Koike K, Miyazaki K. Lymphadenectomy along the left recurrent laryngeal nerve by a minimally invasive esophagectomy in the prone position for thoracic esophageal cancer. Surg Endosc. 2010 Dec;24(12):2965-73. doi: 10.1007/s00464-010-1072-4. Epub 2010 May 22.
PubMed 20495981Park SY, Kim DJ, Yu WS, Jung HS. Robot-assisted thoracoscopic esophagectomy with extensive mediastinal lymphadenectomy: experience with 114 consecutive patients with intrathoracic esophageal cancer. Dis Esophagus. 2016 May;29(4):326-32. doi: 10.1111/dote.12335. Epub 2015 Feb 26.
PubMed 25716873van der Sluis PC, Ruurda JP, Verhage RJ, van der Horst S, Haverkamp L, Siersema PD, Borel Rinkes IH, Ten Kate FJ, van Hillegersberg R. Oncologic Long-Term Results of Robot-Assisted Minimally Invasive Thoraco-Laparoscopic Esophagectomy with Two-Field Lymphadenectomy for Esophageal Cancer. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1350-6. doi: 10.1245/s10434-015-4544-x. Epub 2015 May 29.
PubMed 26023036Cerfolio RJ, Wei B, Hawn MT, Minnich DJ. Robotic Esophagectomy for Cancer: Early Results and Lessons Learned. Semin Thorac Cardiovasc Surg. 2016 Spring;28(1):160-9. doi: 10.1053/j.semtcvs.2015.10.006. Epub 2015 Oct 30.
PubMed 27568155Suda K, Ishida Y, Kawamura Y, Inaba K, Kanaya S, Teramukai S, Satoh S, Uyama I. Robot-assisted thoracoscopic lymphadenectomy along the left recurrent laryngeal nerve for esophageal squamous cell carcinoma in the prone position: technical report and short-term outcomes. World J Surg. 2012 Jul;36(7):1608-16. doi: 10.1007/s00268-012-1538-8.
PubMed 22392356
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03713749
- Acronym / sponsor ID
- 201800322A3C601
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Robotic esophagectomy, Video-assisted thoracoscopic esophagectomy, Recurrent laryngeal nerve lymh node, Esophageal squamous cell carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Shanghai Chest Hospital, Tianjin Medical University Cancer Institute and Hospital
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 22 Apr 2022 (estimated)
- Study completion
- 22 Dec 2022 (estimated)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.
Detailed description
Radical lymph node dissection (LND) along the recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question as to whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.
The investigators will conduct a multicenter, open-label, randomized controlled trial (termed REVATE) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as 1) failure to remove lymph nodes along the left RLN or 2) occurrence of left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Esophagectomy (RE) | Experimental | Device: Robot esophagectomy (RE)Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy. |
| Video-assisted thoracoscopic esophagectomy (VATE) | No intervention | –Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18~80
- Histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN LND.
- Patients should have a performance status 0, 1 or 2 according to the European Clinical Oncology Group.
- Surgical resectable(cT1~4a, N0~3, M0)
- Written informed consent
Key exclusion criteria (4 listed)
- Previous major thoracic surgery rendering minimal invasive approach unfeasible
- prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up
- inability to provide oral or written informed consent.
- pre-existed vocal cord dysfunction will also be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot esophagectomy (RE)Patients in RE group will receive Robotic-assisted surgery in thoracic phase. | Device | Robot Esophagectomy (RE) |
Primary outcome
Rate of unsuccessful LND along the left RLN
Time frame: Till 6 months postoperatively
Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a nexile laryngoscope within one week of surgery. RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary [i.e., recovering within 6 months] versus permanent [i.e. not recovering within 6 months]); and type of treatment required (type I: no therapy required; type II: injury requiring an elective surgical procedure; type III: injury requiring an urgent surgical procedure)
20 secondary outcomes
The number of nodes removed along the right and left RLN
Time frame: The pathological analysis will be finished within 2 weeks.
Post esophagectomy pneumonia rate
Time frame: Duration of hospital stay, an expected average of 2~3 weeks
Rate of major postoperative complication
Time frame: Duration of hospital stay, an expected average of 2~3 weeks
In hospital, 30 day and 90 day mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 90 days
R0 resection rate
Time frame: The pathological analysis will be finished within 2 weeks.
Operation time(thoracic phase)
Time frame: Day of surgery
Operation time(abdominal)
Time frame: Day of surgery
Total operation time
Time frame: Day of surgery
Unexpected events and complications occurring during surgery
Time frame: Day of surgery, up to 24 hours after surgery.
Blood loss during surgery
Time frame: Day of surgery, up to 24 hours after surgery.
Rate of thoracotomy conversion
Time frame: Day of surgery, up to 24 hours after surgery.
Length of mechanical ventilator use after surgery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Length of intensive care unit stay after surgery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Length of postoperative hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Re-intubation rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Re-entry ICU rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks
Overall survival rate
Time frame: Assessed 24/36/60 months after surgery
Disease free survival rate
Time frame: Assessed up to 24/36/60 months after surgery
Hospital Anxiety and Depression Scale (HADS)
Time frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.
European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18
Time frame: pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Background: PubMed 22504922Udagawa H, Ueno M, Shinohara H, Haruta S, Kaida S, Nakagawa M, Tsurumaru M. The importance of grouping of lymph node stations and rationale of three-field lymphoadenectomy for thoracic esophageal cancer. J Surg Oncol. 2012 Nov;106(6):742-7. doi: 10.1002/jso.23122. Epub 2012 Apr 13.
- Background: PubMed 16718401Mizutani M, Murakami G, Nawata S, Hitrai I, Kimura W. Anatomy of right recurrent nerve node: why does early metastasis of esophageal cancer occur in it? Surg Radiol Anat. 2006 Aug;28(4):333-8. doi: 10.1007/s00276-006-0115-y. Epub 2006 May 23.
- Background: PubMed 26464155Sato Y, Kosugi S, Aizawa N, Ishikawa T, Kano Y, Ichikawa H, Hanyu T, Hirashima K, Bamba T, Wakai T. Risk Factors and Clinical Outcomes of Recurrent Laryngeal Nerve Paralysis After Esophagectomy for Thoracic Esophageal Carcinoma. World J Surg. 2016 Jan;40(1):129-36. doi: 10.1007/s00268-015-3261-8.
- Background: PubMed 12715226Fujita H, Sueyoshi S, Tanaka T, Fujii T, Toh U, Mine T, Sasahara H, Sudo T, Matono S, Yamana H, Shirouzu K. Optimal lymphadenectomy for squamous cell carcinoma in the thoracic esophagus: comparing the short- and long-term outcome among the four types of lymphadenectomy. World J Surg. 2003 May;27(5):571-9. doi: 10.1007/s00268-003-6913-z. Epub 2003 Apr 28.
- Background: PubMed 15780563Gockel I, Kneist W, Keilmann A, Junginger T. Recurrent laryngeal nerve paralysis (RLNP) following esophagectomy for carcinoma. Eur J Surg Oncol. 2005 Apr;31(3):277-81. doi: 10.1016/j.ejso.2004.10.007.
- Background: PubMed 20884018Berry MF, Atkins BZ, Tong BC, Harpole DH, D'Amico TA, Onaitis MW. A comprehensive evaluation for aspiration after esophagectomy reduces the incidence of postoperative pneumonia. J Thorac Cardiovasc Surg. 2010 Dec;140(6):1266-71. doi: 10.1016/j.jtcvs.2010.08.038. Epub 2010 Sep 29.
- Background: PubMed 10594510Hulscher JB, van Sandick JW, Devriese PP, van Lanschot JJ, Obertop H. Vocal cord paralysis after subtotal oesophagectomy. Br J Surg. 1999 Dec;86(12):1583-7. doi: 10.1046/j.1365-2168.1999.01333.x.
- Background: PubMed 22668811Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603.
- Background: PubMed 26196135Zhou C, Zhang L, Wang H, Ma X, Shi B, Chen W, He J, Wang K, Liu P, Ren Y. Superiority of Minimally Invasive Oesophagectomy in Reducing In-Hospital Mortality of Patients with Resectable Oesophageal Cancer: A Meta-Analysis. PLoS One. 2015 Jul 21;10(7):e0132889. doi: 10.1371/journal.pone.0132889. eCollection 2015.
- Background: PubMed 22552194Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
- Background: PubMed 20495981Noshiro H, Iwasaki H, Kobayashi K, Uchiyama A, Miyasaka Y, Masatsugu T, Koike K, Miyazaki K. Lymphadenectomy along the left recurrent laryngeal nerve by a minimally invasive esophagectomy in the prone position for thoracic esophageal cancer. Surg Endosc. 2010 Dec;24(12):2965-73. doi: 10.1007/s00464-010-1072-4. Epub 2010 May 22.
- Background: PubMed 25716873Park SY, Kim DJ, Yu WS, Jung HS. Robot-assisted thoracoscopic esophagectomy with extensive mediastinal lymphadenectomy: experience with 114 consecutive patients with intrathoracic esophageal cancer. Dis Esophagus. 2016 May;29(4):326-32. doi: 10.1111/dote.12335. Epub 2015 Feb 26.
- Individual participant dataSharing planned: Undecided
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Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot esophagectomy (RE) in people with Esophageal Squamous Cell Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of unsuccessful LND along the left RLN (time frame: Till 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713749, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.